U.S. patent application number 15/436902 was filed with the patent office on 2017-06-08 for methods and systems for monitoring intrabody tissues.
This patent application is currently assigned to Sensible Medical Innovations Ltd.. The applicant listed for this patent is Sensible Medical Innovations Ltd.. Invention is credited to Shlomi BERGIDA, Ilan KOCHBA, Nadav MIZRAHI, Dan RAPPAPORT, Amir RONEN, Amir SAROKA.
Application Number | 20170156626 15/436902 |
Document ID | / |
Family ID | 42211768 |
Filed Date | 2017-06-08 |
United States Patent
Application |
20170156626 |
Kind Code |
A1 |
KOCHBA; Ilan ; et
al. |
June 8, 2017 |
METHODS AND SYSTEMS FOR MONITORING INTRABODY TISSUES
Abstract
A method for monitoring an intrabody region of a patient. The
method comprises intercepting electromagnetic (EM) radiation from
the intrabody region in a plurality of EM radiation sessions during
a period of at least 6 hours, calculating a dielectric related
change of the intrabody region by analyzing respective the
intercepted EM radiation, detecting a physiological pattern
according to said dielectric related change and outputting a
notification indicating the physiological pattern.
Inventors: |
KOCHBA; Ilan; (ModiIn,
IL) ; RAPPAPORT; Dan; (Tel-Aviv, IL) ; SAROKA;
Amir; (Tel-Aviv, IL) ; BERGIDA; Shlomi; (Udim,
IL) ; MIZRAHI; Nadav; (Tel-Aviv, IL) ; RONEN;
Amir; (Ramot Menashe, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sensible Medical Innovations Ltd. |
Kfar Neter |
|
IL |
|
|
Assignee: |
Sensible Medical Innovations
Ltd.
Kfar Neter
IL
|
Family ID: |
42211768 |
Appl. No.: |
15/436902 |
Filed: |
February 20, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13254852 |
Sep 5, 2011 |
9572511 |
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PCT/IL2010/000182 |
Mar 4, 2010 |
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15436902 |
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12676381 |
May 6, 2010 |
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PCT/IL2008/001199 |
Sep 4, 2008 |
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13254852 |
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12676385 |
Jul 1, 2010 |
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PCT/IL08/01198 |
Sep 4, 2008 |
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13254852 |
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61157261 |
Mar 4, 2009 |
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60969963 |
Sep 5, 2007 |
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60969965 |
Sep 5, 2007 |
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60969966 |
Sep 5, 2007 |
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60969963 |
Sep 5, 2007 |
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60969965 |
Sep 5, 2007 |
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60969966 |
Sep 5, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/024 20130101;
A61B 5/4869 20130101; A61B 5/4504 20130101; A61B 5/0059 20130101;
A61B 5/412 20130101; A61B 5/4848 20130101; A61B 5/021 20130101;
A61B 5/4842 20130101; A61B 5/0075 20130101; A61B 5/4076 20130101;
A61B 5/7282 20130101; A61B 5/05 20130101; A61B 5/72 20130101; A61B
5/0507 20130101; A61B 5/7246 20130101 |
International
Class: |
A61B 5/05 20060101
A61B005/05; A61B 5/00 20060101 A61B005/00 |
Claims
1. A wearable monitoring device for monitoring an intrabody region
during a stress ergometry procedure and/or stress exercise,
comprising: at least one probe comprising at least one transducer
configured for transmitting to and intercepting electromagnetic
(EM) radiation from at least one intrabody region of the lungs of a
patient while said patient is performing a stress examination test;
a processing unit configured for: calculating a dielectric related
change of the at least one intrabody region by analyzing respective
said intercepted EM radiation, and detecting a fluid accumulation
rate and/or a fluid amount in the lungs during said stress
examination test according to said dielectric related change; an
output unit configured for outputting a notification indicative of
said fluid accumulation rate and/or a fluid amount.
2. The wearable monitoring device of claim 1, wherein said
detecting includes: estimating an expected signal of intercepted
electromagnetic radiation, and matching said estimated signal to a
detected signal of intercepted electromagnetic radiation, thereby
detecting said fluid accumulation rate and/or said fluid
amount.
3. The wearable monitoring device of claim 1, wherein said at least
one probe (204) is configured for intercepting said electromagnetic
(EM) radiation from a reference intrabody region of said patient;
wherein said processing unit (201) is further configured for
calculating a reference dielectric related change in said reference
intrabody region according to said intercepted EM radiation;
wherein said processing unit is further configured to detect said
fluid accumulation rate and/or said fluid amount according to a
combination of said dielectric related change and reference
dielectric related change.
4. The wearable monitoring device of claim 1, wherein the at least
one transducer of said at least one probe (204), a reporting unit,
and said processing unit (201) are contained in a housing.
5. The wearable monitoring device of claim 1, wherein said
processing unit (201) is configured for calibrating said
intercepting EM radiation with a breathing cycle of said patient
taking into account expected differences between the signals
received during inhalation and the signals received during
exhalation.
6. The wearable monitoring device of claim 1, wherein said EM
radiation passes through the intrabody region.
7. The wearable monitoring device of claim 1, wherein said
dielectric related change reflects a change in a plurality of
properties of said intrabody region.
8. The wearable monitoring device of claim 7, wherein said
plurality of properties comprises a member of a group consisting of
a density, a size, a shape, and a concentration of fluids.
9. A method for monitoring an intrabody region, comprising:
intercepting electromagnetic (EM) radiation from the at least one
intrabody region of a patient performing a stress examination test
in at least one EM radiation session; calculating a dielectric
related change of the at least one intrabody region by analyzing
respective said intercepted EM radiation, and detecting a fluid
accumulation rate and/or a fluid amount in the lungs during said
stress examination test according to said dielectric related
change; and outputting a notification indicating said accumulation
rate and/or said fluid amount.
10. The method of claim 9, wherein said fluid accumulation is a
blood accumulation.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/254,852, filed on Sep. 5, 2011, which is a
National Phase of PCT Patent Application No. PCT/IL2010/000182
having International Filing Date of Mar. 4, 2010, which claims the
benefit of priority of U.S. Provisional Patent Application No.
61/157,261 filed on Mar. 4, 2009.
[0002] U.S. patent application Ser. No. 13/254,852 is also a
continuation-in-part of U.S. patent application Ser. No. 12/676,381
filed on of May 6, 2010, which is a National Phase of PCT Patent
Application No. PCT/IL2008/001199 having International Filing Date
of Sep. 4, 2008, which claims the benefit of priority of U.S.
Provisional Patent Application Nos. 60/969,963, 60/969,965, and
60/969,966, all filed on Sep. 5, 2007.
[0003] U.S. Patent Application No. 13/254,852 is also a
continuation-in-part of U.S. patent application Ser. No. 12/676,385
filed on of Jul. 1, 2010, which is a National Phase of PCT Patent
Application No. PCT/IL2008/001198 having International Filing Date
of Sep. 4, 2008, which claims the benefit of priority of U.S.
Provisional Patent Application Nos. 60/969,963, 60/969,965, and
60/969,966, all filed on Sep. 5, 2007.
[0004] The contents of the above applications are all incorporated
by reference as if fully set forth herein in their entirety.
FIELD AND BACKGROUND OF THE INVENTION
[0005] The present invention, in some embodiments thereof, relates
to a system and a method for monitoring a pathological condition of
a patient and, more particularly, but not exclusively, to a system
and a method for monitoring pathological and physiological
condition of a user using EM radiation.
[0006] During the last years, various methods and devices have been
developed for diagnosing intrabody tissues using electromagnetic
(EM) radiation. For example, U.S. Pat. No. 6,061,589, published on
Sep. 5, 2000 describes a microwave antenna for use in a system for
detecting an incipient tumor in living tissue such as that of a
human breast in accordance with differences in relative dielectric
characteristics. In the system a generator produces a non-ionizing
electromagnetic input wave of preselected frequency, usually
exceeding three gigahertz, and that input wave is used to irradiate
a discrete volume in the living tissue with a non-ionizing
electromagnetic wave. The illumination location is shifted in a
predetermined scanning pattern. Scattered signal returns from the
living tissue are collected and processed to segregate skin tissue
scatter and to develop a segregated backscatter or return wave
signal; that segregated signal, in turn, is employed to detect any
anomaly indicative of the presence of a tumor or other abnormality
in the scanned living tissue.
[0007] In another example, U.S. Pat. No. 6,919,838 published on
Jul. 19, 2005, describes a scanner or imager that employs a
plurality of microwave transmitters that emit a multiplicity of
pulses, which are received by a plurality of receivers. An object
or person positioned between the transmitters and receivers can be
scanned and subsequently imaged in extreme detail, due to the broad
spectral content of the pulses.
[0008] International Patent Application Number IL2008/001199, filed
on Sep. 4, 2008, which is incorporated herein by reference,
describes a method for monitoring thoracic tissue. The method
comprises intercepting electromagnetic (EM) radiation from thoracic
tissue of a patient in continuous or intermittent EM radiation
sessions during a period of at least 24 hours, detecting dielectric
coefficient of the thoracic tissue by analyzing respective
intercepted EM radiations, and outputting a notification indicating
the change. The intercepted EM radiationis changed as an outcome of
physiological processes as well as thoracic movements which occur
during the period. The intercepted EM radiation may be reflections
of EM radiation transmitted toward the thoracic tissue, EM
radiation passing through the thoracic tissue, and/or EM radiation
scatter from the thoracic tissue.
[0009] International Patent Application Number IL2008/001198, filed
on Sep. 4, 2008, which is incorporated herein by reference,
describes a wearable monitoring device for monitoring at least one
biological parameter of an internal tissue of an ambulatory user.
The wearable monitoring device comprises at least one transducer
configured for EM radiation to the internal tissue and intercepting
EM radiation therefrom in a plurality of continuous or intermittent
EM radiation sessions during at least 24 hours, a processing unit
configured for analyzing respective intercepted EM radiation and
identifying a change in the at least one biological parameter
accordingly, a reporting unit configured for generating a report
according to the change, and a housing for containing the at least
one transducer, the reporting unit, and the processing unit, the
housing being configured for being disposed on the body of the
ambulatory user.
SUMMARY OF THE INVENTION
[0010] According to some embodiments of the present invention there
is provided a method for monitoring an intrabody region of a
patient. The method comprises intercepting a plurality of
electromagnetic (EM) radiations from the intrabody region in a
plurality of EM radiation sessions during a period of at least 6
hours, calculating a dielectric related change of the intrabody
region by analyzing the plurality of electromagnetic radiations,
detecting a physiological pattern according to the dielectric
related change, and outputting a notification indicating the
physiological pattern.
[0011] Optionally, the patient is an ambulatory patient and the
intercepting being performed during a period of at least 12
hours.
[0012] Optionally, the dielectric related change reflects a change
in a plurality of properties of the intrabody region.
[0013] More optionally, the plurality of properties comprises a
member of a group consisting of a density, a size, a shape, and a
concentration of fluids.
[0014] Optionally, the calculating comprising registering EM
radiations intercepted during a first of the plurality of EM
radiation sessions with a second of the plurality of EM radiation
sessions.
[0015] Optionally, the intrabody region comprises a cancerous
tissue and the physiological pattern is a reaction of the cancerous
tissue to an oncological therapy.
[0016] More optionally, the physiological pattern is a reaction of
the cancerous tissue to a member selected from a group consisting
of: a chemotherapy cycle, a biologic treatment, an antineovascular
agent and a radiation treatment.
[0017] Optionally, the physiological pattern is a reaction of the
intrabody region to a medical operation performed on the
patient.
[0018] Optionally, the method further comprises automatically
dispensing a medical substance into the patient according to the
physiological pattern.
[0019] Optionally, the notification comprises a recommendation to a
medical procedure according to the physiological pattern.
[0020] More optionally, the medical procedure comprising a member
of a group consisting of: a dosage of a medical agent, a dispensing
of a medical substance, a radiation protocol, a rehabilitation
process, and a diagnosis procedure.
[0021] Optionally, the detecting is performed by combining at least
one biological parameter of the patient with the dielectric related
change for detecting the physiological pattern.
[0022] More optionally, wherein the at least one biological
parameter comprises a member of a group consisting of: an
electrocardiogram (ECG) signal, a temperature, a body orientation,
a body acceleration, a hemodynamic parameter, CO.sub.2 saturation,
O.sub.2 saturation, a pulse wave and a blood pressure.
[0023] Optionally, the detecting is performed by combining at least
one diagnostic result related to the intrabody region with the
dielectric related change for detecting the physiological
pattern.
[0024] Optionally, the intrabody region is a pulmonary tissue and
the notification is indicative of atelectasis.
[0025] Optionally, the physiological pattern is an expected
dielectric related change indicative of a blood accumulation in an
intrabody tissue.
[0026] Optionally, the intrabody region comprises a cerebral tissue
and the physiological pattern is indicative of a cerebral
edema.
[0027] Optionally, the patient is a non compliant patient selected
from a group consisting of an intensive care patient, a new-born
suffering from respiratory distress syndrome, a patient under
general anesthesia, a child patient and a toddler patient.
[0028] Optionally, the method further comprises using an imaging
modality for imaging the intrabody tissue and registering the
monitoring device with the imaging for performing the
intercepting.
[0029] Optionally, the method further comprises using an imaging
modality for detecting at least one characteristic of the intrabody
tissue, the detecting is performed according to the at least one
characteristic.
[0030] Optionally, the physiological pattern based on a reference
parameter extracted from a modality imaging the intrabody
region.
[0031] Optionally, the patient is an intubated patient and the
intrabody region comprises a pulmonary tissue.
[0032] Optionally, the patient is an anesthetized patient.
[0033] According to some embodiments of the present invention there
is provided a method for monitoring an intrabody region. The method
comprises performing stress ergometry on a patient according to a
stress examination test, intercepting a plurality of
electromagnetic (EM) radiations from the at least one intrabody
region of the patient in at least one EM radiation session,
calculating a dielectric related change of the at least one
intrabody region by analyzing the plurality of electromagnetic
radiations, detecting a physiological pattern according to the
dielectric related change, and outputting a notification indicating
the physiological pattern.
[0034] According to some embodiments of the present invention there
is provided a monitoring device for detecting a physiological
pattern of an intrabody region. The monitoring device comprises a
probe configured for intercepting plurality of electromagnetic (EM)
radiations from the intrabody region of a patient, a processing
unit calculating a dielectric related change of the intrabody
region by analyzing the plurality of EM radiations and detecting a
physiological pattern according to the dielectric related change,
and an output unit configured for outputting a message indicating
the physiological pattern. The probe and the processing unit are
configured for respectively performing the intercepting and the
analyzing in a plurality of EM radiation sessions during a period
of at least 6 hours.
[0035] Optionally, the output unit is connected to a medical device
providing a treatment to the patient, the medical device being
configured for providing the treatment according to the
message.
[0036] More optionally, the medical device comprises a respiration
machine being configured to apply artificial respiration to the
patient, the respiration machine being configured for adjusting the
artificial respiration according to the message.
[0037] According to some embodiments of the present invention there
is provided a monitoring device for detecting a physiological
pattern of an intrabody region. The monitoring device comprises at
least one probe configured for intercepting a plurality of
electromagnetic (EM) radiations from an intrabody region of a
patient and from a reference intrabody region of the patient, at
least one processing unit configured for calculating a dielectric
related change in the intrabody region and a reference dielectric
related change in the reference intrabody region according to the
plurality of EM radiations and identifying a physiological pattern
according to a combination of the dielectric related change and
reference dielectric related change, and an output unit configured
for outputting a notification indicating the physiological
pattern.
[0038] According to some embodiments of the present invention there
is provided a method for monitoring a physiological pattern of an
intrabody region. The method comprises fixating a monitoring device
in relation to a body of a non-compliant patient, intercepting
plurality of electromagnetic (EM) radiations from the at least one
intrabody region of the patient in at least one EM radiation
session, calculating a dielectric related change of the at least
one intrabody region by analyzing the plurality of EM radiations,
detecting a physiological pattern according to the dielectric
related change, and outputting a notification indicating the
physiological pattern.
[0039] Optionally, the intercepting is performed while the patient
is transported.
[0040] Unless otherwise defined, all technical and/or scientific
terms used herein have the same meaning as commonly understood by
one of ordinary skill in the art to which the invention pertains.
Although methods and materials similar or equivalent to those
described herein can be used in the practice or testing of
embodiments of the invention, exemplary methods and/or materials
are described below. In case of conflict, the patent specification,
including definitions, will control. In addition, the materials,
methods, and examples are illustrative only and are not intended to
be necessarily limiting.
[0041] Implementation of the method and/or system of embodiments of
the invention can involve performing or completing selected tasks
manually, automatically, or a combination thereof. Moreover,
according to actual instrumentation and equipment of embodiments of
the method and/or system of the invention, several selected tasks
could be implemented by hardware, by software or by firmware or by
a combination thereof using an operating system.
[0042] For example, hardware for performing selected tasks
according to embodiments of the invention could be implemented as a
chip or a circuit. As software, selected tasks according to
embodiments of the invention could be implemented as a plurality of
software instructions being executed by a computer using any
suitable operating system. In an exemplary embodiment of the
invention, one or more tasks according to exemplary embodiments of
method and/or system as described herein are performed by a data
processor, such as a computing platform for executing a plurality
of instructions. Optionally, the data processor includes a volitile
memory for storing instructions and/or data and/or a non-volatile
storage, for example, a magnetic hard-disk and/or removable media,
for storing instructions and/or data. Optionally, a network
connection is provided as well. A display and/or a user input
device such as a keyboard or mouse are optionally provided as
well.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0043] Some embodiments of the invention are herein described, by
way of example only, with reference to the accompanying drawings.
With specific reference now to the drawings in detail, it is
stressed that the particulars shown are by way of example and for
purposes of illustrative discussion of embodiments of the
invention. In this regard, the description taken with the drawings
makes apparent to those skilled in the art how embodiments of the
invention may be practiced.
[0044] In the drawings:
[0045] FIG. 1 is a flowchart of a method for monitoring an
intrabody tissue of a patient during a monitoring period of more
than 6 hours, according to some embodiments of the present
invention;
[0046] FIG. 2 is a flowchart of a method for monitoring an
intrabody tissue of a patient by a plurality of EM radiation
sessions, according to some embodiments of the present
invention;
[0047] FIG. 3 is a graph of a waveform intercepted from a simulated
tumor after a dielectric related property thereof has been
changed;
[0048] FIG. 4 is a schematic illustration of an exemplary intrabody
region that surrounds the simulated tumor of FIG. 3;
[0049] FIG. 5 is a graph of waveforms intercepted after a plurality
of dielectric related properties of a simulated intrabody region,
such as a bone tumor, that has been changed;
[0050] FIG. 6 is a schematic illustration of an exemplary intrabody
region that surrounds the bone tumor depicted in FIG. 5;
[0051] FIG. 7 is a flowchart of a method for monitoring an
intrabody tissue of a patient performing a stress examination,
according to some embodiments of the present invention;
[0052] FIG. 8 is a schematic illustration of a monitoring device
for monitoring dielectric related changes in an intrabody tissue,
according to some embodiments of the present invention; and
[0053] FIG. 9 is a flowchart of a method for detecting a
pathological pattern of a pulmonary tissue by calculating a
difference between the dielectric coefficients of tissues from the
left lung and the right lung, according to some embodiments of the
present invention.
DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0054] The present invention, in some embodiments thereof, relates
to a system and a method for monitoring pathological condition of a
patient and, more particularly, but not exclusively, to a system
and a method for monitoring pathological and physiological
condition of a user using EM radiation.
[0055] According to some embodiments of the present invention there
is provided a system and a method for detecting a physiological
pattern, such as pathological pattern and non-pathological pattern
of one or more intrabody tissues, for example from a selected
region, by monitoring dielectric related changes thereof.
[0056] A dielectric property or coefficient of a material describes
its interaction with EM fields; it is represented by a frequency
dependent complex number describing the electrical permittivity and
the conductivity of the material, as known in the art. In this
patent and the International Patent Applications Numbers
IL2008/001198 and IL2008/001199, filed on Sep. 4, 2008 which are
incorporated herein by reference, dielectric coefficient refers to
complex dielectric coefficient representing both the permittivity
and conductivity characteristics of the material. Different
intrabody regions include one or more tissues which are
characterized by different complex dielectric coefficients
referring the permittivity and conductivity. The dielectric
parameters of tissues have been measured, researched and organized
by Gabriel at el. and serve as a golden standard. For example, a
tissues containing high water content like muscle are characterized
by a relatively high complex dielectric coefficient in both its
real and imaginary part, where dry tissues like fat have low
relative complex dielectric coefficient in both its real and
imaginary parts. The complex dielectric coefficient of an intrabody
region is affected greatly by its fluid content. For example, a
normal fat tissue with relatively low fluid content is
characterized by a relatively low dielectric coefficient with
relative permittivity of 5.44 and conductivity of 0.0535 S/m, while
a muscle tissue is characterized by higher blood content and
relatively high dielectric coefficient, relative permittivity of
54.8 and conductivity of 0.978 S/m.
[0057] A dielectric related property of a tissue or region means a
property that is related to the dielectric property thereof. Such a
dielectric related property affects the electro-magnetic radiation
which interact with the tissue that incident upon the related
region; changes in dielectric related properties of a region may
change any one or more of the following: the amplitude of the EM
radiation which is intercepted after interacting with the tissue,
delay effects on the intercepted EM radiation, phase of the
intercepted EM radiation, frequency content of the intercepted EM
radiation, dispersion of the intercepted EM radiation and/or any
similar properties of the intercepted EM radiation. The intercepted
EM radiation may be reflections of EM radiation transmitted toward
the tissue, EM radiation passing through the tissue, and/or EM
radiation scattered from the tissue.
[0058] A dielectric related change can result from a change in one
or more dielectric properties of specific tissues within an
intrabody region as well as changes in the configuration of tissues
within the region. For example, in case of a change in the
intrabody region, such as when blood fills the tissue parenchyma, a
change in the dielectric coefficient of the region is expected.
Similarly, an ischemic region within a tissue will change its
properties to fibrotic tissue reflected by lower dielectric
coefficient. In another example, a region may have a dielectric
related change as a result of a cancerous tumor within the region
growing in size or becoming more vascularized.
[0059] As used herein, a physiological pattern means an estimated
change in one or more dielectric properties of a respective
intrabody region comprising one or more tissues, such as a
connective tissue and a tissue of a bone, a muscle, a joint, a
cartilage, and/or one or more internal organs, for example the
lungs, the kidneys, and the brain. Optionally, the physiological
pattern may be a pathological pattern of an expected change in an
intrabody region that occurs in response to an operation, a
treatment, a medical condition, and/or pathology. Additionally or
alternatively, the physiological pattern may be a non-pathological
pattern, such as an expected change that is triggered by a medical
treatment, such as an oncological treatment, such as chemotherapy,
an expected reaction to a medical substance, and an expected
reaction to a physical exercise. The change of the physiological
state of a region is monitored over the measurement period
resulting in a dynamic pattern. The physiological state may be
defined by various parameters describing different aspects of the
physiological state. Thus, the physiological pattern may include
the time course of the different parameters over time.
[0060] The method comprises intercepting a plurality of
electromagnetic (EM) radiations from the one or more intrabody
tissues of a patient in a plurality of continuous or intermittent
EM radiation sessions during a period of 6 hours or more. The
plurality of EM radiations sessions may include the transmitting of
EM radiation toward the intrabody region, the transmitting of EM
radiation which interacts with the intrabody region, the
intercepting of reflections of EM radiation from the intrabody
region, the intercepting of EM radiation that interacts with one or
more bodily tissue and/or the detection of responses of EM
radiation to the intrabody region. Then, a dielectric related
change is calculated by analyzing the changes in the intercepted EM
waves during the EM radiation sessions and between radiation
sessions over the monitoring period. The dielectric related change
allows detecting a physiological pattern of the intrabody tissue
and outputting a notification indicating the pathological pattern
to the patient or to a caretaker thereof.
[0061] The monitoring and assessment of the dielectric related
changes of intrabody regions in hospitalized and unhospitalized
patient allows monitoring physiological and anatomical changes in
the intrabody region, for example for detecting a growth and/or
reduction in the size of a tumor. By detecting such changes, which
are indicative of pathological patterns, a more effective and safe
treatment may be given. For example, a titration of drug treatment
may be adjusted according to the type, rate, and/or intensity of
the detected pathological pattern. Another example is a situation
in which the definitive treatment of the tumor is surgical but the
tumor is too large or developed in a difficult location for
removal. In such cases a, neoadjuvant chemotherapy is necessary to
reduce the tumor size. The monitoring allows notifying a caretaker
and/or the patient when to proceed with the surgery. In another
example, an administration of excess drugs may be avoided. It
should be noted that by using such a non invasive procedure, other
monitoring procedures, which are usually more risky and/or
incurring exposure to ionizing radiation, may be avoided. In
addition, such monitoring may allow generating an indication that
assists in a hospital discharge timing decision.
[0062] In other embodiments of the present invention, there is
provided a system and a method for monitoring dielectric related
changes of one or more intrabody tissues during a stress
examination. In such a manner, the accumulation of fluids in the
monitored intrabody tissues may be detected during the stress
phase, improving the sensitivity and specificity of the stress
examination to pathological states. In other embodiments of the
present invention, there is provided a system and a method for
monitoring dielectric related changes of one or more intrabody
tissues of low or non compliant patients and/or patients which are
transported to a medical center to receive a medical care.
[0063] Before explaining at least one embodiment of the invention
in detail, it is to be understood that the invention is not
necessarily limited in its application to the details of
construction and the arrangement of the components and/or methods
set forth in the following description and/or illustrated in the
drawings and/or the Examples. The invention is capable of other
embodiments or of being practiced or carried out in various
ways.
[0064] Reference is now made to FIG. 1, which is a schematic
illustration of a method 100 for monitoring an intrabody region of
a patient during a monitoring period of more than 6 hours by
analyzing dielectric related properties thereof, according to some
embodiments of the present invention.
[0065] As shown at 99, the method is based on detecting a
dielectric related change 99 in the EM properties of the intrabody
region. The dielectric related change 99 is detected by evaluating
the dielectric related properties of the intrabody region in a
plurality of EM radiation sessions which are held during a period
of 6 hours or more. The monitoring may be adjusted to take into
account changes in the dielectric related properties of the
monitored intrabody region, such as changes which occur as an
outcome of a reaction to a medical treatment, a change of
physiological state and body movements.
[0066] Optionally, the monitoring is performed by a wearable
monitoring device, a probe and/or by a device having wearable
probes, for example similar to the devices which are described in
International Patent Applications Numbers IL2008/001198 and
IL2008/001199, filed on Sep. 4, 2008, which are incorporated herein
by reference. For brevity, each one of these devices may be
referred to herein as a monitoring device or a probe.
[0067] In such embodiments, as shown at 98, the locations of the
intrabody regions and/or their effect on the intercepted EM
radiation may be identified before the monitoring begins in a
process which may be referred to herein as a registration process.
Optionally, the registration process is performed with respect to
an imaging modality such as, a computerized tomography (CT), a
magnetic resonance imager (MRI), a positron emission tomography
(PET)-CT, and/or an EM tomography device that is used to identify
the location of the intrabody region so that the monitoring device
may be positioned and/or diverted to intercept the EM radiation
therefrom. For example, the imaging modalities may be used for
identifying the location of a cancerous tissue, such as a tumor,
for example a hepatic tumor and a chest tumor. The identification
allows, inter alia, the positioning of the monitoring device and/or
the probe thereof in a manner that the EM radiation is emitted
toward the intrabody region. In addition, the identification allows
initializing a number of base values for calibrating the analysis
that is described in relation to 104 in FIG. 1. The identification
may be similarly performed using an imaging modality use in
association with a therapeutic modality such a cryoprobe or
heatprobe. Optionally, the registration process is performed using
known registration processes and known imaging modalities for
registration of specific intrabody regions, such as tumors,
cerebral tissues, and/or bleeding tissues.
[0068] Optionally, the monitoring device, which is disposed or
attached to the body, performs the EM radiation sessions during an
imaging process which is performed by either of the abovementioned
imaging modalities. Such EM radiation sessions allow a definite
position of the monitoring device in relation to a region of
interest (ROI) that includes the intrabody region and defined by
the imaging modalities. Optionally, the anatomical reconstruction
of the ROI and its surrounding tissue are forwarded to the
monitoring device and allow calculating an expected signal subject
to expected changes of the physiological state of the intrabody
region. Finite element methods may incorporate this anatomical
information to compute the reflections and/or otherwise affected EM
waves which are intercepted during the EM sessions. For brevity, a
reflection means any EM radiation which interacts with an intrabody
region, such as the ROI, for example EM radiation which are
transmitted via the intrabody region, scattered from the intrabody
region, and/or reflected from the intrabody region.
[0069] In addition, the effects of the physiological changes may be
simulated to produce an expected signal which is matched when
detected and notified. For example, a hepatic tumor may shrink as a
result of chemotherapy, for instance go through a tumor remission.
A computerized model of the entire EM irradiated region may
calculate the resultant signal, and in case of a shrinkage of the
tumor may be simulated and produce an expected signal, used for
detection of such a state. For example, reference is now also made
to FIGS. 3 and 4 which are, respectively, a graph of waveforms
intercepted after a dielectric related property of a simulated
intrabody region, such as a tumor has been changed and a schematic
illustration of an exemplary intrabody region that surrounds the
tumor. FIGS. 3 and 4 depict a three dimensional finite element
simulation which has been conducted with realistic anatomical
dimensions as may be provided by an imaging modality, such as CT,
MRI and PET. In the simulation, a lung tumor 3104 in the lung 3109,
below a layer of skin 3107, a layer of fat 3105, and a layer of
muscle 3108. The simulation simulated an increase and a decrease in
the tumor's size, as an estimated consequence of ineffective and
effective treatment. The simulation included a pulse transmitted
from an EM transducer 3106, such as the one described below, width
equal to about 350 picoseconds (ps). In the simulation, the pulse
propagated through a 3 mm layer of skin 3107, 10 mm layer of fat
3105, and 10mm layer of muscle 3108 into the lung 3109. The center
of the tumor 3104 is 30 mm deep the lungs. During the simulation,
the radius of the simulated tumor 3104 was increased to simulate an
ineffective treatment and decreased to simulate an effective
treatment. The tumor dielectric coefficient is relatively high due
to estimated high blood content around the tumor. For example, its
dielectric coefficient is close to that of the muscle. In
particular, the simulation results, which are depicted in FIG. 3,
show waveforms in the time domain representing the difference
between the following reflections which are received from the tumor
3104: 3103 is waveform intercepted after the simulated tumor
reducing from 5 mm to 0 mm, 3102 is waveform intercepted after a
simulated tumor shrinks from a radius of 10 mm to a radius of 5 mm,
and 3101 is waveform intercepted after a simulated tumor shrinks
from 10 mm to 0 mm. The simulation explicitly exemplify how a
dielectric related change shows that different changes in a
dielectric related property, such as the size of the intrabody
region, which is optionally a tumor, are distinguished from one
another.
[0070] Optionally, the monitoring device is designed for monitoring
dielectric related changes of the intrabody region of an ambulatory
user, for example as described in Application Number IL2008/001198,
filed on Sep. 4, 2008, which the content thereof is incorporated
herein by reference. In such an embodiment, the monitoring device
comprises at least one transducer for delivering EM radiation to
the internal tissue and intercepting EM radiation therefrom in a
plurality of EM radiation sessions during a period of at least 6
hours, a processing unit configured for analyzing the intercepted
EM radiation and identifying the presence or the absence of one or
more pathological patterns accordingly, a reporting unit configured
for generating a report according to changes in the intercepted EM
radiation, and a housing for containing the at least one
transducer, the reporting unit, and the processing unit. The
monitoring device is capable of providing indications for proper
disposing of the sensor on the patient body, or of providing
indications for proper positioning of the apparatus with respect to
a monitored region of interest (ROI) that includes the intrabody
region, such that, the ROI is observed in a manner similar to the
previous observations and such that the measurements and
reconstructed properties of the ROI state may be compared with
previous estimations from previous measurements. For the sake of
the operation, the patient may be frequently monitored by standard
imaging modalities for extracting of a range of ROI related
parameters. These parameters are used for a calibration of the
device. It should be noted that the monitoring device may interface
with and/or integrate into other sensors, imaging modalities,
treatment devices and information technology systems of different
organizations, such as hospitals, caretaker clinics, long term care
facilities, nursing homes, home care service providers, call
centers, and the like. As used herein, a caretaker means a
physician, a nurse, a family member, an affiliate, a medical center
staff member, a call center, or any entity that manages and/or
should have access to the specific information related to the
medical condition of the monitored patient and/or a team of one or
more of these caretakers.
[0071] Optionally, the identification of the location of the
intrabody region, which is optionally a cancerous tissue, is
identified using an imaging modality, according to a registration
process. Optionally, the output of the registration process is a
set of instructions that allow the patient or a caretaker to
position a monitoring device, for example as defined below in
relation to FIG. 8, to emit EM radiation and to capture the
reflection thereof, for example as depicted in 101 and 102 of FIG.
2. Optionally, the registration process defines the location of a
tumor in relation to well defined anatomical structures and/or
fiduciary markers, such as specific markers which are attached to
the patient. For example, if the intrabody region is located in the
chest, the registration process may output positioning instructions
by analyzing distances from specific ribs or from the chest
vertebrae. Similarly, patches can be attached to the skin of the
patients or guides could be drilled into the pelvis in case of
prostate tumor so as to be used as fiduciary markers.
[0072] Additionally or alternatively, the output of the calibration
process may include information about the current state of the
intrabody region and/or region, optionally accounting for various
parameters that are further characterized such as the density, the
size, the shape, and the necrosis parameters. Optionally, these
parameters may include EM sensor related information for example
regarding the sensor absolute position and/or relative position to
one or more intrabody regions, external-body objects and/or other
sensors. Optionally, an intrabody region, such as a tumor, may be
indentified by one or more imaging modalities, such as CT, PET and
fluoroscopy. For example, if the intrabody region is a tumor, these
modalities may provide information related thereto, such as the
density the fluid content, the vascularization level, the effect of
fibrosis, the functional and/or the metabolic properties of the
cancerous tissue characterized by the blood supply may be provided
and used for optimal calibration process performed by the system
used in the forgoing monitoring. The updated physiological state is
used for expecting some prognostic stages, either desired or not.
For example, the monitoring device may be used for monitoring a
patient treated for a lung cancer, at a stage of
neovascularization. While receiving chemotherapy, it is expected
that the treatment reduces the vascularization that leads to
necrosis and later to shrinkage of the tumor and more fibrosis.
[0073] As depicted in 99, the positioning of the monitoring device
allows detecting dielectric related changes in intrabody region.
The dielectric related changes are optionally detected by a
plurality of EM radiation sessions which are performed during a
period of 6, 12, 24, 48, 72 hours, intermediate or longer periods
and/or during a period during which the patient's medical condition
is to be monitored, for example during a stress examination and/or
a transportation for medical care, as described below. Reference is
now also made to FIG. 2, which is a flowchart of a method for
monitoring an intrabody region, according to some embodiments of
the present invention. Optionally, blocks 98, 99 and 104-105 are as
depicted in FIG. 1. However, FIG. 2 further depicts blocks 101-103
that depict one of the EM radiation sessions.
[0074] First, as shown at 101, EM radiation is beamed from a
monitoring device, for example in a similar manner to describe in
International Patent Applications Numbers IL2008/001198 and
IL2008/001199, filed on Sep. 4, 2008 which are incorporated herein
by reference.
[0075] Then, as shown at 102, a reflection of the beamed EM
radiation is captured. In some embodiments of the present
invention, the beamed EM radiation is in the range of 3 MHz to 60
GHz, inclusive. In such a mode, time gating may be used for
focusing on a specific reflection, as further detailed in
International Patent Applications Numbers IL2008/001198 and
IL2008/001199, filed on Sep. 4, 2008 which are incorporated herein
by reference. The shape of the pulse may be generated using
different shaping techniques. It should be noted that though this
document mostly refer to an analysis that is based on the
interception of reflections of the EM radiation from the intrabody
region, an analysis which is based on EM radiation that is
intercepted after it passed through the intrabody region may be
performed additionally or alternatively.
[0076] In some embodiments of the present invention, as further
described below, the beamed EM radiation is narrowband waves,
optionally modulated, optionally in a predefined range of frequency
bands, as described in International Patent Applications Numbers
IL2008/001198 and IL2008/001199, filed on Sep. 4, 2008 which are
incorporated herein by reference.
[0077] In some embodiments of the present invention, sequential
measurements are registered and only these measurements are
compared to previous measurements taken at the same physiological
state and posture. Methods for registering a position of the
monitoring device with respect to a region of interest, for a
detection of a posture, and a detection of similar physiological
states, are described in International Patent Applications Numbers
IL2008/001198 and IL2008/001199, filed on Sep. 4, 2008 which are
incorporated herein by reference.
[0078] Now, as shown at 102, a reflection of the beamed EM
radiation is captured. As described above, a change in the
intrabody region is detected by detecting changes in the dielectric
related properties thereof, for example as described below.
[0079] After the reflected EM radiation has been captured, analysis
of the captured signals, for example as shown at 103, is performed.
The analysis may take into account the posture of the user and/or
the placement of the monitoring device that is designed for
receiving the reflection from the monitored tissue. In addition, it
may use two measurements acquired in at distinct physiological
state to compute a differential signal, for example as described
below and in International Patent Applications Numbers
IL2008/001198 and IL2008/001199, filed on Sep. 4, 2008 which are
incorporated herein by reference.
[0080] Optionally, as shown at 106, blocks 101-103 are repeated in
a plurality of transmission and interception sessions, referred to
herein as EM radiation sessions, for gathering continuous and/or
discrete signals indicative of dielectric related changes in the
intrabody region. These dielectric related changes may be
indicative to various pathological patterns and/or pathological
tissue behaviors, for example as described below. For example, in
each EM radiation session, a dielectric related property is
measured during one or more intervals. Optionally, each EM
radiation session lasts between few pico-seconds and few hours,
optionally minutes. In use, the EM radiation which is intercepted
during a number of EM radiation sessions allow calculating the
dielectric related change which may be indicative of a change of
fluid content within a biological tissue and/or region. Such a
dielectric related change may reflect for example a bodily heat
change, a necrosis, a fibrosis, and/or a change in the blood supply
to the monitored intrabody region.
[0081] Multiple EM radiation sessions measured might be required
for monitoring changes over long periods of time. In such cases the
measurements comparing the intrabody detected parameters requires
that the patient will be in a certain posture, physiological state
and placed in a specific position relative to the measured
intrabody region. Different mechanisms described in this patent the
International Patent Applications Numbers IL2008/001198 and
IL2008/001199, filed on Sep. 4, 2008 which are incorporated herein
by reference, describe the posture detector, physiological state
detector, registration and calibration mechanism essential to deal
with changes over time of the patient.
[0082] The dielectric related change may be calculated by matching
one or more dielectric related properties from one or more EM
radiation sessions. Optionally, the dielectric related change
reflects a pattern of one or more dielectric related properties
which are recorded during a period of 1, 2, 4, 6, 8, 10, 12 and 24
hours, days, weeks, and/or months. For example, a user may position
the EM probe to monitor the dielectric related properties of the
intrabody region every 1, 2, 4, 6, 8, 10, 12 and 24 hours, days,
weeks, and/or months and to calculate accordingly a dielectric
related change. It should be noted that the probe may include one
or more transducers for transmitting and intercepting the EM
radiation and/or separate one or more transmitters and/ one or more
receivers. Optionally, the transducers, receivers, and/or
transmitters are located in proximity to one another, for example
one the same plane and/or in the same housing. Optionally, the
transducers, receivers, and/or transmitters are positioned one in
front of the other, allowing the reception of EM radiation that
pass through the intrabody region.
[0083] As shown at 104, the dielectric related change allows
calculating medical indices of interest, which are optionally based
on physiological, anatomical and/or clinical parameters. The
medical indices of interest may be used for detecting and/or
evaluating physiological patterns which are indicative of normal
and/or pathological tissue behaviors of the monitored intrabody
region. Such an evaluation may be performed by comparing measured
dielectric related changes to expected and/or estimated values of
dielectric related changes in various conditions. This information
may be compared and evaluated with respect to biological
parameters, such as an electrocardiogram (ECG) signal, a
temperature, a body orientation, a body acceleration, a hemodynamic
parameter, CO.sub.2 saturation, O.sub.2 saturation, a pulse wave
and a blood pressure and/or vital signs estimation, such as the
heart rate, and breathing, for example as described in
International Patent Applications Numbers IL2008/001198 and
IL2008/001199, filed on Sep. 4, 2008, which are incorporated herein
by reference.
[0084] In some embodiments of the present invention,
characteristics, such as a change in a position, a size, a
configuration and/or a state of an intrabody region and/or region,
for example an operated tissue, a preoperated tissue, a
postoperated tissue, cancerous tissue, such as a tumor, a change of
intubation fixation, and a traumatized tissue, such as a tissue
damaged or otherwise effected by a traumatic brain injury, are
detected and/or measured by analyzing the dielectric related change
in the intrabody region. The change, which may indicate a size
growth and/or size reduction and/or change of tissue concentration
within a region and/or change of fluid content and/or change of the
composition and/or configuration of tissues in the intrabody region
may be detected by analyzing changes in the reflected EM which are
caused by changes to the dielectric related properties of the
intrabody regions.
[0085] As shown at 105, the physiological patterns may be used in
the analysis and may affect alert decisions made by the processing
unit which may result in notifying the patient and/or medical
caretaker. Such a notification may be used for alarming the patient
and/or her medical caretaker with regard to an improvement and/or a
decline in her status. Such alarming may reduce the time between
the development of a certain health complication and a treatment
thereafter.
[0086] Optionally, the notification provided in 105 includes a
recommendation for a titration of a given treatment. Additionally
or alternately, the recommendation includes a predetermined
accepted range which matches the expected risk to patient.
Similarly, the recommendation may include a change of a
chemotherapy protocol as elaborated below. Additionally or
alternately, the notification is replaced with a message, such as a
set of instructions to a medical treatment device, such as a
medical substance dispenser and/or a respiration machine. For
example, the set of instruction control adjust, and/or define a
range for a medicament dispense and/or for configuring and/or
reconfiguring parameters of a respiration machine. In use, the
output of the monitoring device may be forwarded to the medical
treatment device through a communication channel. Optionally, the
processing of the EM interceptions and the analysis thereof is
integrated within the medical treatment device. In such a manner, a
medical treatment device, such as a respiration machine and a
medical substance dispenser may be integrated with a probe for
monitoring dielectric related changes, for example as described
herein.
[0087] In some embodiments of the present invention, the analysis
allows calculating a clinical state or change thereof of a patient
based on an integrative index. The clinical state or change thereof
is determined based on an analysis of a combination of the
physiological patterns and/or the physiological patterns' change
rate and/or biological parameters such as an electrocardiogram
(ECG) signals, a temperature, a body orientation, a body
acceleration, a hemodynamic parameter, CO.sub.2 saturation, O.sub.2
saturation, a pulse wave and a blood pressure and/or vital signs
and/or detected trends of vital signs which are estimated based on
analysis of the reflected EM radiation and/or other medical
sensors, such as electrocardiogram (ECG), myogram (EMG), an
ultrasound transducer, a pulse oximeter, a blood pressure sensor, a
tiltmeter, an accelerometer, and coagulometer. The integrative
index is optionally scaled and/or color coded to provide intuitive
follow-up of the clinical status of the patient. Optionally, the
monitoring device includes an adjustment unit for receiving
adjustment information related to the monitored patient from the
medical sensors. In such an embodiment the processing unit is
configured for calculating the clinical state or change thereof
according to the adjustment information.
[0088] Optionally, the monitoring device has a set up mode and a
sequential monitoring mode. In use, the aforementioned registration
process is performed during the set up mode, for example based on
anatomical information as well as the physiological state of the
ROI that is characterized by the various biological parameters.
[0089] Additionally or alternatively, the patient or the caretaker,
at the set-up mode, may define specific events, characterized by
predefined changes, for notifications. For example, the caretaker
may define an urgent notification in case of abrupt changes in the
rate of tumor diminution or a detection of a sudden bleeding. For
example, the caretaker or the patient may define alerts to changes
such as an increase of more than 20% in the size of an intrabody
region, such as a tumor, or a bleeding of more then 100 cc.
Alternatively, the monitoring device may be configured for
providing a notification, such as an alert, if a reduction in the
necrosis process, an initiation of bleeding, and/or a change of the
rate of the bleeding is detected.
[0090] The setup process may be repeated every time imaging of
another modality is conducted, for refining the registration and
calibration.
[0091] In the sequential monitoring mode, the aforementioned EM
radiation sessions are performed. The dielectric related changes,
which are detected during the EM radiation sessions, may be used
for estimating a relative change for characterizing the current
status of the intrabody tissue.
Oncological Monitoring
[0092] According to some embodiments of the present invention, the
intrabody region is a cancerous tissue, such as a tumor, and the
dielectric related changes are indicative of changes in the
cancerous tissue. The method allows monitoring the tumor's response
to an oncological treatment, for example radiations, chemotherapy,
pre-radiation chemotherapy, pre-surgical chemotherapy (neoadjuvant
therapy), hormonal therapy, and anti angiogenesis therapies, on an
hourly, daily, and/or weekly or and/or other periodic basis. Some
therapies have an estimated affect on the intrabody region. In such
an embodiment, detected pathological patterns, for example these
detected in 104, may reflect a change in a tumor size, either
regression or growth, a change in the composition of a tumor, for
example in the necrosis percentage thereof, a change in the
vascular density of the tumor, or a change in the bleeding rate the
tumor may have caused, a change in morphology of a tumor which is
affected by the amount of blood therein, and/or a change in the
blood supply in the vicinity of the tumor. For example, see Juweid
M E: Positron-Emission Tomography and Assessment of Cancer Therapy.
N Engl J Med 2006; 354:496-507I and Schiller J. H Noninvasive
Monitoring of Tumors: N Engl J Med 359:418, Jul. 24, 2008, which
are incorporated herein by reference.
[0093] As described above, the monitoring device may be used for
providing a physiological pattern based on a plurality of
dielectric related properties. Reference is now also made to FIGS.
5 and 6 which are, respectively, a graph of waveforms intercepted
after a plurality of dielectric related properties of a simulated
intrabody region, such as a bone tumor, which have been changed and
a schematic illustration of an exemplary intrabody region that
surrounds the bone tumor.
[0094] FIGS. 5 and 6 depicts the outcome of a simulation made using
an EM transducer, is demonstrated in the following simulation. FIG.
5 depicts a differential waveform from a bone tumor 3202. The
simulated model is described in 3203 and based on simulated
anatomical information that may be provided by one or more imaging
modalities, such as CT or MRI, for a bone tumor diagnosis. Two
possible physiological effects were simulated, usually relevant in
different stages of the bone tumor, for example shrinkage of a
dimension and a change of bone tumor content due to necrotic
processes while preserving its dimension. In particular, the
simulation emulates an intercepted radiation which is transmitted
from the transducer 3113 propagates through a 5 mm layer of skin
3107 into a layer of cortical outer bone 3110, which is surrounded
by a 10 mm layer of fat 3105 and a 10 mm layer of muscle 3108, and
reflected from the bone tumor 3104. The bone radius is 15 mm and
the center of the bone includes a bone marrow tissue with 5 mm
radius. The differential waveforms presented in FIG. 5 show the
difference in the reflection. Waveform 3112 depicts shrinkage of a
simulated bone tumor from 8 mm high blood content bone tumor to a 4
mm high blood content bone tumor. Waveform 3113 depicts a change in
the blood content in a simulated bone tumor from high to low, where
its dimensions of the simulated bone tumor remain the same, 4 mm
radius. These results exemplify that different changes in the size
or the shape of an intrabody region can be distinguished by
identifying different dielectric related changes.
[0095] In such an embodiment, the notification 105 may be generated
to indicate whether the chemotherapy has a beneficial and/or a
detrimental effect on the cancerous tissue and optionally to what
degree.
[0096] For example, the notification may be used for adjusting a
titration process. In such an embodiment, the concentration of a
medical substance which is given during the therapy is determined
according to the notification. Optionally, the concentration of the
medical substance is determined manually. In such an embodiment the
caretaker or the patient prepares a medicament with a concentration
which is selected according the notification. Optionally, the
notification includes a concentration recommendation. Additionally
or alternatively, the concentration of the medical substance is
determined automatically, for example by a dosage unit that
receives the notification. Such an automatic preparation allows
automatic and/or manual dispensing of the medicament.
[0097] Optionally, the dielectric related changes are used for
selecting an appropriate medicament for the patient. Thus, tumor
suppression by the medicament is contingent on the specific
oncogenic pathway that drives tumor development. Such a monitoring
mode enables early detection of adverse reactions to therapy such
as post radiation or chemotherapy induced pneumonitis.
[0098] Optionally, the notification is an alarm generated if the
dielectric related change is indicative of a deviation from the
expected outcomes of a respective chemotherapy cycle or any
identifiable stage of an oncological treatment. In such an
embodiment, a different effect is detected in different
chemotherapy cycles. In particular, a different dielectric related
change is expected in different chemotherapy cycles. For example,
the expected result of a therapy, such as chemotherapy, platinum,
etoposide and/or avastin based therapy, which is applied to a
cancerous tissue, such as a tumor, is expected to cause a tumor to
undergo several changes in a number of consecutive chemotherapy
cycles. During the first chemotherapy cycle, tumor cells die and
the number of blood vessels which lead blood to the tumor
diminishes. Then, during the following chemotherapy cycle, a
necrosis is formed in the tumor. The necrosis causes a subsequent
change in the density of the tumor and an eventual shrinkage in its
size.
[0099] The expected and/or estimated dielectric related change that
is associated with various chemotherapy cycles may be determined
according to clinical experiments and/or a numerical simulation of
the chemotherapy cycles in humans. Optionally, the expected and/or
estimated dielectric related change is adjusted to the medical
information that is related to the monitored patient, for example
the gender, the height, the weight, the body mass index (BMI),
and/or the pathology of the patient.
[0100] If the pathological patterns 104 indicate that the changes
do not respectively occur during the respective chemotherapy
cycles, the notification may indicate that the chemotherapy process
has to be stopped, adjusted, and/or replaced with another therapy.
For example, the patient and/or the caretaker may replace a chosen
therapy, change a used dosage and/or change a medication
protocol.
[0101] Optionally, if the measured dielectric related changes are
not indicative of a change, such as an increase in the rate of
tumor's diminution and/or if the dielectric related changes are
indicative of a change in a slower rate than expected, the treating
caretaker may be alarmed.
[0102] Optionally, the notification is forwarded, wireles sly or by
cable to a central patient management unit, for example as
described in International Patent Application Number IL2008/001199,
filed on Sep. 4, 2008 which are incorporated herein by reference.
In such an embodiment, the notifications may be sent without the
intervention of the patient and may include the complete record of
the treatment. Additionally or alternatively, the notification is
forwarded for the presentation thereof on an external device such
as a medical monitor, a smart phone, and/or personal digital
assistant (PDA) of the patient and/or the caretaker.
[0103] Optionally, the notification comprises a recommendation to a
specific change in the treatment protocol and/or instructions to
perform certain analyses or diagnoses of the intrabody region. For
example, in the current practice, if a tumor increases in size
after two treatment courses lasting a minimum of 6 weeks, a change
in protocol is recommended. Showing an increase in tumor size along
time, may permit the caretaker to change the protocol earlier and
avoid unnecessary toxicity. This is the case in hematologic tumor
such as Non-Hodgkin's Lymphoma which is usually treated with a
C.H.O.P based protocol, and the protocol is substituted if tumor
growth during treatment is demonstrated. Another example applies to
treatment of Hodgkin's Lymphoma in which the tumor increases with
the first-line protocol such as doxorubicin containing ABVD regimen
(doxorubicin, bleomycin, vinblastine dacarbazine).
[0104] As described above, the device may be used for monitoring
cancerous tissues.
[0105] In such an embodiment, the notification may include one or
more estimations pertaining to the benefits of a therapy such as
radiation, chemotherapy or biologic therapy such as Tyrosine kinase
inhibitors directed against the epidermal growth factor receptor
(EGFR).
[0106] Optionally, the monitoring that is performed by the
monitoring device is calibrated according to one or more
physiological processes of the patient. For example, when
monitoring a cancerous tissue that is located at the thorax, such
as a tumor of lung cancer, the calibration is performed according
to the breathing cycle of the patient, taking into account expected
differences between the signals received during inhalation and the
signals received during exhalation, for example as described in
International Patent Applications Numbers IL2008/001198 and
IL2008/001199, filed on Sep. 4, 2008 which are incorporated herein
by reference.
[0107] The relative changes are analyzed with respect to the device
configuration, calibration, thresholds and setup as provided by
manufacturer presets and by the treating caretaker and proper
notifications are sent to the patient and/or directly to the
treating caretaker.
Post-Operative Complications
[0108] According to some embodiments of the present invention, the
intrabody region is a traumatized or potentially traumatized
tissue, such as an operated tissue or a tissue which is related to
an operated organ. In such an embodiment, the monitoring device may
be used for postoperative monitoring of operated tissues and/or
related tissues. Such monitoring may allow an early detection of
post-operative complications of surgeries such as, abdominal,
gynecologic, or thoracic surgeries, for example bleeding within an
abdominal cavity and atelectasis.
[0109] It should be noted that such post-operative complications
may be initiated unexpectedly, like in abdominal bleeding after a
cesarean section (CS), a condition which requires medical
intervention of a member of a treating medical staff. The
monitoring of the operated tissue following specific procedures at
specific locations may reduce or eliminate the requirement of a
human supervision of the patient by a caretaker, such as an
attendant nursing and/or medical staff and/or the use of ancillary
imaging and/or laboratory tests.
[0110] In use, the monitoring device is used for monitoring
dielectric related changes of the operated tissue and/or proximate
or otherwise related tissues. For example, the monitoring device
may be positioned such that it would monitor another tissue segment
that is susceptible to bleeding in the abdomen, for example, the
amount of blood within the chest may decrease as a consequence of
abdominal bleeding and simple monitoring of the breathing signal
would reveal such a decrease. For example, as depicted in FIG. 1,
the monitoring device emits EM radiation toward the operated tissue
and/or the related tissues and captures the reflections and/or
passing EM waves therefrom in a plurality of sessions along a
period of more than 3, 6, 12, 24, 48, 72 hours, intermediate
periods and/or longer periods, as depicted in 101 and 102 and
similarly to the described above. The reflections and/or passing EM
waves which are captured in each session are analyzed for detecting
dielectric related changes which are indicative to pathological
patterns, as shown at 104. The dielectric related changes which are
indicative to postoperative pathological patterns may be determined
according to clinical experiments and/or a numerical simulation of
postoperative pathological patterns in humans. Such a process
allows detecting a dielectric related change that is indicative of
fluid concentration change, such as fluid accumulation, optionally
caused by bleeding. Optionally, the dielectric related changes are
adjusted according to medical information that is related to the
operated patient, for example the gender, the height, the weight,
the body mass index (BMI), and/or the pathology of the patient.
[0111] Optionally, a registration process is performed in parallel
to the performance of the EM radiation sessions, for example as
described in International Patent Applications Numbers
IL2008/001198 and IL2008/001199, filed on Sep. 4, 2008, which are
incorporated herein by reference. In such an embodiment, the
reflections and/or the EM waves may be calibrated according to the
movement, the breathing cycle, and/or the posture of the
patient.
[0112] The ability to notify the patient and/or the caretaker with
regard to internal bleeding may allow diagnosing indications of
hemodynamic shock, which may require complicated treatments that
may save the patient life. An early notification may reduce the
risks which are posed by these complicated treatments.
[0113] As the sessions may be repeated every few seconds, minutes,
and/or hours, an early detection of the fluid accumulation is
allowed. It should be noted that the detection is performed without
a diagnostic imaging procedure, such as ultrasonographic
examination or a computerized tomography scan, and without
laboratory measurements of complete blood counts.
[0114] Optionally, the monitoring device is connected to a
hemodynamic monitoring unit, such as sphygmomanometer and a pulse
oxymeter. In such embodiments, the pathological patterns, which are
detected by an analysis of the EM reflections and/or the EM waves,
may be adjusted and/or calibrated according to outputs of the
hemodynamic monitoring unit, such as blood pressure and pulse
measurements, of the hemodynamic monitoring unit. For example, if
the hemodynamic monitoring unit detects a reduction of blood
pressure to less than 90/60 and/or an increase of pulse to more
than 120 beats per minute. If the detected dielectric related
change is indicative of bleeding, the notification indicates that
there is a high chance for an internal bleeding.
[0115] In addition, many of the patients undergoing abdominal or
thoracic surgery are patients inflicted with several diseases and
comorbidities and require fluid resuscitation and close monitoring
of the post operative period.
[0116] Such monitoring allows detecting atelectasis, which is a
common pulmonary complication in patients which have been treated
with thoracic and upper abdominal procedures. In case of
atelectasis, airways are collapsed, thus, replaced by lung
parenchyma and further with inflammatory agents, which result in
change of regional dielectric coefficient. General anesthesia and
surgical manipulation lead to atelectasis by causing diaphragmatic
dysfunction and diminished chest wall motion due to pain. The
atelectasis may be attributed to a reduced reflex response to
aspiration. In such an embodiment, a bronchial pathway may be
occluded and the distal airways may collapse sequentially. The
atelectasis is typically basilar and segmental in distribution.
[0117] Monitoring internal bleeding after a surgical procedure
allows verifying the reduction of the bleeding flow to a recovery
level and notifying, as described above, if the recovery level is
not decreased in a satisfactory rate. Additionally or
alternatively, the monitoring allows generating an urgent alert in
case of unexpected bleeding. Similarly, post-operative atelectasis
may be developed and cause shortness of breath and multiple
complications such as sepsis.
[0118] Optionally, as described above, the motoring device is as
defined in International Patent Application Number IL2008/001198,
filed on Sep. 4, 2008, which is incorporated herein by reference.
In such an embodiment, the monitoring device is designed for
monitoring the intrabody regions of hospitalized and unhospitalized
patients, in various environments, for example, home, hospital,
during rest or stressed activities. The monitoring device provides
an estimation of the regional dielectric property.
[0119] As described above, the monitoring device may be used for
monitoring post operation complications, such as an intense
bleeding rate, an initiation of unexpected bleeding and
atelectasis.
[0120] As described above, the monitoring device detects dielectric
related changes. These changes may be indicative of changes which
occur in internal body regions.
[0121] Optionally, the monitoring device is designed to scan sub
regions in a sequential and/or non sequential depths and/or to
focus on a specific location.
[0122] Optionally, the monitoring device is designed for detecting
the complications by diagnosing the symptoms; the system provides
early detection prior to consequent deterioration of clinical
state, in a manner which enables proper treatment to avoid such
deterioration.
[0123] Similarly to the described above, the monitoring device may
have set up and sequential monitoring modes. When the device is in
a set up mode, data pertaining to the operation that has been
performed on or in relation to the intrabody region is provided by
the user. In such a manner, a selected pattern may be monitored,
such as an expected bleeding rate, as assessed by the physician at
that time, e.g., 60-100 cc per hour. The received data may be used
for defining a pattern of expected dielectric related changes
and/or parameters and the analysis, which is based on the
intercepted EM radiation, may be based on the defined pattern. For
example, if in a certain surgery, a bleeding above 100 cubic
centimeters (cc) is considered pathological, a respective alert may
be defined. When a dielectric related change that is indicative to
the accumulation of such an amount of blood or more is detected,
the respective alert is presented to the patient and/or forwarded
to the caretaker.
[0124] When the monitoring device is in a sequential monitoring
mode, the aforementioned monitoring sessions are performed, as
described above. Each monitoring session is used for characterizing
the operated tissue current status is used for estimating a
relative change.
[0125] The relative changes are analyzed according to the device
configuration presets and according to manual configuration set by
the medical staff and proper notifications are sent to the patient
and/or directly to the medical staff thereof. Optionally, the
notification may comprise suggestions of titration of the therapy
that is provided to the patient and/or the treating caretaker
and\or the directly to a therapy device.
Cerebral Edema
[0126] According to some embodiments of the present invention, the
intrabody region is a traumatized cerebral tissue, such as a
cerebral tissue of a patient suffering from a traumatic brain
injury (TBI).
[0127] Patients involved in accidents, such as a motor vehicle
accident (MVA), and in others situations may suffer from TBI in
which the injury is inflicted on brain tissues. TBI may involve
damage to the brain parenchyma and edema which evolves after a
period of between a few hours and a few days after the injury. Such
cerebral edema consists of intracellular pressure followed by
vasogenic edema. Therefore, patients with TBI are usually put under
a neurocritical care during which the cerebral edema is monitored.
Such a neurocritical care allows delivering patient tailored
targeted therapy to the patients. There is a critical importance to
distinguish between bleeding that is drained and bleeding that
accumulates and may result in a rise of the intracranial pressure,
a life threatening condition. Therefore, patients are kept under
supervision for at least 48 hours.
[0128] As described above, the monitoring device is configured for
monitoring dielectric related changes in an intrabody region and/or
region over a period of few hours and/or days. In the present
embodiment, the monitoring device may be used for monitoring
dielectric related changes which are indicative of the accumulation
of blood in the brain. Placing the monitoring device in proximity
to the injured side of the cranium and performing a plurality of EM
radiation sessions, optionally continuously, allows monitoring
dielectric related changes which are indicative of the development
or nondevelopment of cerebral edema and generating notifications
may alert the caretaker and/or the patient as to the accumulation
of cerebral edema and optionally a recommendation to intervene for
optimal treatment and/or before complications may occur. The
dielectric related changes which are indicative of development or
nondevelopment of cerebral edema may be determined according to
clinical experiments and/or a numerical simulation of the
development or nondevelopment of cerebral edema in humans.
Optionally, the dielectric related changes are adjusted according
to the medical information that is related to the monitored
patient, for example the gender, the height, the weight, the body
mass index (BMI), and/or the pathology of the patient.
[0129] Moreover, it may ease the supervision constraint. As
described above, the monitoring device may be registered using an
imaging modality. As elaborated above, a registration process may
provide the entire information for allowing the detection of the
expected physiological patterns
Non Compliant Patient Monitoring
[0130] Optionally, the monitoring device is designed to monitor or
perform a measurement of low or non compliant patients, such as
intensive care patients, new-born babies suffering from respiratory
distress syndrome, patients under general anesthesia, for example
during a surgery and children particularly of pre-school age.
[0131] The monitoring of dielectric related changes in pulmonary
tissues allows early detection of respiratory problems in non
compliant patients, such as the accumulation of air between the
lungs and chest cavity walls, also known as pneumothorax, and/or
partial blockage of the air passages by secretions. The early
detection may prevent a deterioration of the medical condition of
the patients and/or the development of complications. For example,
the detection of one lung intubation (OLI) during anesthesia or
intensive care may prevent a development of possible complications
such as tissue hypoxia and irreversible brain damage.
[0132] As described above, the monitoring device may be a wearable
device. Optionally, wearable device includes an attachment unit for
attaching the wearable monitoring apparatus to the body of the
user, and/or any other electronic component that may be worn out by
the use of the wearable monitoring apparatus.
[0133] Similarly, it may be attached to the patient for a period,
providing similar continuous monitoring of the patient For example
as described in International Patent Applications Numbers
IL2008/001198 and IL2008/001199, filed on Sep. 4, 2008 which are
incorporated herein by reference. As such, the device may be used
for monitoring patients outside of a hospital and/or any other
medical service facility. In such an embodiment, the monitoring
device may be used for monitoring patients, such as trauma
patients, whom are to be transported to a medical center and may
encounter respiratory difficulties. For example, a monitoring
device may be placed on each side of the thorax of the patient, in
proximity to the lungs, directly monitoring the dielectric related
changes associated with breathing process of the chest cavity, and
generating a notification when detecting an irregular dielectric
related change. Optionally, the monitoring device is used for
monitoring changes in the pulmonary fluid levels in patients,
optionally in low or non compliant patients, which are transferred
from one location to another, for example from an accident scene or
a battle field to a hospital. For example, traumatic injuries such
as pneumothorax, and/or the hemothorax, and/or to accumulation of
airway secretions and/or blood may be detected and monitored along
the transportation to the medical facility. Such monitoring allows
notifying the caretaker when the patient's mechanical ventilation
is subjected to mechanical hazards which may lead to changes in the
pulmonary fluid levels or breathing patterns, such as a change of
the fixation and suctioning secretions and positioning of a
ventilation tube. It should be noted that when intubation is
performed in suboptimal circumstances, for example when the
caretaker is not experienced in performing the procedure, the
chances that the ventilation tube may be misplaced are increased.
Placing the ventilation tube too deep may cause lack of ventilation
to one lung or due to damage the chest wall.
[0134] Optionally, the measurements by the monitoring device may be
adjusted according to the ventilation parameters which are provided
by the ventilation respiration machine. Optionally, the monitoring
device issues warnings and/or changes parameters in the ventilation
machine, for example, increases the pressure and/or the volume when
some or all of the EM radiation sessions indicate poor expansion of
the lung over a respiratory cycle.
[0135] In addition, the monitoring allows detecting breathing or
ventilation problems which are indicative of patient distress,
which may lead to irreversible danger to vital organs such as the
brain and the heart.
[0136] It should be noted that by using a plurality of monitoring
devices, a single caretaker may monitor a plurality of patients in
a battlefield, an accident site or any other event in which more
than one patient is found.
Acute Respiratory Distress Syndrome (ARDS)
[0137] Acute Respiratory distress syndrome (ARDS) is a severe lung
disease caused by a variety of direct and indirect issues. It is
characterized by inflammation of the lung parenchyma and increased
permeability of pulmonary blood vessels leading to impaired gas
exchange with concomitant systemic release of inflammatory
mediators causing inflammation, hypoxemia and frequently resulting
in multiple organ failure. This condition is often fatal, usually
requiring mechanical ventilation in addition to treatment aimed at
the inciting event and admission to an intensive care unit.
[0138] A less severe form is called acute lung injury (ALI). Today,
ALI and ARDS patients are treated by intubation of the lungs,
antibiotic and supportive care.
[0139] Optionally, the monitoring device is used for monitoring ALI
and ARDS patients which are low or non compliant patients, or
detection and monitoring of aspiration pneuomonia which may evolve
into ALI condition.
Neonatal RDS
[0140] Respiratory distress syndrome of neonates is a condition in
which the lungs have not reached maturity and therefore the
neonates suffer from dyspnea and hypoxemia. The lack in surfactant
causes the airways to be collapsed and impairs gas exchange. The
condition is usually manifested by a specific pattern in Xray
imaging called "groung glass" appearance. The condition is usually
treated by intratubal administration of surfactant and supportive
respiratory care.
[0141] In such an embodiment, the monitoring device may be placed
on the newborn's chest or the premature baby's incubator for
providing a notification to the caretaker that is indicative of a
process that causes a dielectric related change within the lung
parenchyma. Such a notification assists the caretaker in
determining whether a further dose of surfactant is needed and/or
when to withdraw a ventilation tube.
Stress Ergometry
[0142] Reference is now made to FIG. 7, which is a flowchart of a
method for monitoring an intrabody region during a stress ergometry
procedure and/or stress exercise, according to some embodiments of
the present invention. As used herein a stress ergometry and/or a
stress exercise are diagnosis procedures based on either
electrocardiography and/or echocardiography. It should be noted
that the stress ergometry and/or a stress exercise may include any
diagnosis procedure which is based on electrocardiography,
echocardiography, and/or any examination of a bodily activity
and/or functioning of the patient and/or an organ thereof.
[0143] Blocks 99, 104, and 105 are as described above in relation
to FIG. 7. However, as shown at 301, FIG. 7 depicts a method in
which the dielectric related changes are monitored during a stress
exercise. In such an embodiment, the monitored intrabody region is
active while the patient performs a stress examination. In such an
embodiment, fluid that is accumulated in the lungs during a stress
examination may be monitored and a notification that is indicative
of the accumulation rate and/or amount is outputted. Optionally,
the monitoring is performed as described in International Patent
Applications Numbers IL2008/001198 and IL2008/001199, filed on Sep.
4, 2008, which are incorporated herein by reference.
[0144] Exercise electrocardiography is a common, non-invasive test
for diagnosing various pathologies, such as myocardial ischemia.
Extensive data shows that the test has a sensitivity level of 68%
and a specificity of 77%, see Noninvasive tests in patients with
stable coronary artery disease. N Engl J Med, 344:1840, Jun. 14,
2001, clinical practice, which is incorporated herein by reference.
Other non-invasive tests, such as radionuclide imaging and stress
echocardiography have better sensitivity and specificity. The
monitoring of the dielectric related changes during the stress
examination allows detecting high-risk patients in which the
measured lung water content increases and in which a more
aggressive treatment is advisable. It may improve the sensitivity
and specificity of each of the described exercise tests.
[0145] Optionally, the monitoring device is used for diagnosing
coronary abnormalities based on dielectric related changes of
pulmonary tissues which are detected during a stress
examination.
[0146] Optionally, before the monitoring is initiated, the
monitoring device is calibrated. During the calibration stage, an
EM radiation session or sessions for assessing the level of fluids
within the pulmonary tissues is performed. Such a measurement may
be used for detecting changes which may occur during the stress
examination, after the stress examination is initiated.
Exemplary Monitoring Device
[0147] Reference is now also made to FIG. 8, which is a schematic
illustration of a set of components 200 of an exemplary monitoring
device, according to some embodiments of the present invention.
Optionally, the exemplary monitoring device is designed as a
wearable and/or as a stationary monitoring device, for example as
described in International Patent Applications Numbers
IL2008/001198 and IL2008/001199, filed on Sep. 4, 2008, which are
incorporated herein by reference. The monitoring device may be used
for implementing any of the aforementioned method.
[0148] The exemplary device which is depicted in FIG. 8 comprises a
central processing unit (CPU) and/or a digital signal processing
(DSP) which may be referred to herein as a processing unit 201.
Optionally, the processing unit 201 runs a real-time operating
system (RTOS) that is responsible for coordinating all functions of
the monitoring device 100. The processing unit 201 is optionally
used for analyzing the outputs of the one or more front-end sensors
204 which are described below. Optionally, the one or more
front-end sensors 204 capture signals which are forwarded to the
processing unit 201 that calculates medical indices of interest,
which is optionally based on physiological, anatomical and/or
clinical parameters. The medical indices of interest are based on a
dielectric related change that is reflected from the signals. The
medical indices of interest may be used for detecting a
pathological pattern. For example, the processing unit 201 may
compare between the calculated parameters and a set of one or more
predefined values and sets flags accordingly, for example as
described below. The data which is calculated by the processing
unit 201 is optionally used for generating one or more alerts
and/or notifications, as further described above. It should be
noted, that the term processing unit means a local processing unit,
a distributed processing unit, and/or a remote processing unit
which is used for performing the functioning of the processing unit
which is described herein. In an embodiment in which the processing
unit is remote, the data which is forwarded to the processing unit
is transmitted for remote processing by the remote processing
unit.
[0149] The monitoring device 100 further comprises a memory unit
202, such as a non volatile memory, that is designed for storing
the operating system and parameters which are needed for the
functioning of the monitoring device 100. Optionally, the memory
unit 202 is used for recording readings of reflections from the
intrabody regions and/or calculations which are based thereupon,
for example as further described above. Optionally, as outlined
above, the dielectric related properties of the monitored intrabody
region, such as the fluid contents, for example tissue fluid
contents which are calculated according to EM waves from the
tissue, are recorded in the memory unit 202. Such a recording
allows examining changes in the predefined and/or known biological
patterns, such as in the pathological pulmonary fluid content,
along a period that lasts between few hours and days, for example
as outlined above. The recording allows calculating one or more
baselines and/or the identification of a normal range which are
adjusted according to the specific user. Optionally, the memory
unit 202 is used for recording readings of medical sensors which
are connected to the monitoring device 100 and/or embedded therein.
Optionally, the memory unit 202 is used for storing additional
information, such as application executables codes, configuration
files for the processing unit 201, preset parameters, long term
state parameters and tables. The memory unit 202 may be used for
storing additional user related data, such as the user
identification information, version information, user specific
thresholds, authentication and/or security keys.
[0150] The monitoring device 100 further comprises a rapid access
volatile memory unit 206, such as a dynamic random access memory
(DRAM), a synchronous DRAM (SDRAM), and/or any other volatile
memory for storing data that is needed to be accessed in a limited
time for short terms. It may be interfaced by the processing unit
201, the below mentioned designated IC and/or any other component
of the monitoring device 100.
[0151] Optionally, the monitoring device 100 comprises a designated
processing unit 203, such as a designated integrated circuit (IC),
for example an application-specific integrated circuit (ASIC) or a
field-programmable gate array (FPGA) that contains logic blocks and
programmable interconnects which are programmed to implement some
of the functions required to process the data from the sensors
front-ends. The designated processing unit 203 communicates with
the processing unit 201, the memory unit 202, and/or with other
components of the device for various tasks. Additionally or
alternatively, the designated processing unit 203 may also
implement any of the other blocks as an integrative solution. For
example, the FPGA or ASIC may incorporate the processing unit 201
and/or another processing unit. Optionally, the logic blocks are
programmed to implement monitoring methods as described above.
[0152] As described above and depicted in FIG. 8, the monitoring
device 100 further comprises one or more probes, such as front-end
sensors 204, for example EM transceivers, for transmitting a
plurality of electromagnetic (EM) waves toward the thorax of the
user and for capturing reflections thereof from an area of interest
or any EM waves passing therethrough, such as the pulmonary tissues
of the user. In some embodiment, the beam is transmitted in a
desired pulse and allows the capturing of a reflection thereof from
various areas on the surface of the user's body. Optionally, the
capturing is adjusted according a selected operational mode, for
example according to a selected swept frequency, a selected
frequency hopping chirp, and the like. Other modes and/or gating
patterns according to which the beam is transmitted and allows the
capturing thereof are described in International Patent
Applications Numbers IL2008/001198 and IL2008/001199, filed on Sep.
4, 2008, which are incorporated herein by reference.
[0153] In such a mode, time gating may be used for focusing on a
specific reflection, for example as described in International
Patent Applications Numbers IL2008/001198 and IL2008/001199, filed
on Sep. 4, 2008, which are incorporated herein by reference. The
shape of the pulse may be generated using different shaping
techniques.
[0154] In some embodiments of the present invention, the front-end
sensors 204 include EM transducers which are designed for
transmitting one or more pulses of EM radiation and intercepting
the EM radiation from monitored tissues and/or organs of the
monitored patient. Optionally, the monitored tissues are internal
tissues, such as the pulmonary tissue. The intercepted EM radiation
is converted to a signal having different features that allows
evaluating dielectric related properties of the monitored tissues
and/or organs, for example as described below. The EM transducers
are optionally designed to continuously transmitting and analyzing
the intercepted EM radiation for monitoring dielectric related
properties of the monitored tissues and/or organs, which may be
referred to herein, for brevity, as the monitored tissues.
[0155] Optionally, in order to achieve high range resolution while
keeping the implementation relatively simple close range detection
pulses are used. The shorter the pulse the higher is the space
resolution. Such pulses are known in the art and therefore not
discussed in great detail.
[0156] Optionally, the EM transducer is designed to transmit one or
more stable frequency continuous wave (CW) radio signals and then
to receive the intercepted EM radiation from internal tissues
and/or objects. The one or more CW radio signals may be
transmitted, simultaneously or sequentially. For example, the CW
radio signals may be transmitted in frequencies such as 900 MHz and
2.5 GHz. The CW radio signals may sweep one or more frequency
ranges allowing measuring intercepted EM radiation in wide range of
frequencies. CW signals as well as any narrow band signal may
achieve high dynamic range by using narrow filtering around the
used frequencies. The narrow filter may track the signal over time,
for example, it may sweep together with the signal.
[0157] Optionally, the spatial and/or timing information is
extracted by using multiple frequencies. Such information is mainly
conveyed in the received phase of the signal. Optionally where a
low number of frequencies which are not well spread over a large
bandwidth results in a relatively poor or void time resolution. A
single frequency allows generating differential measurements for
measuring a movement and/or a displacement of a tissue and/or an
organ by sensing a change over time of mainly the phase but also
the amplitude of the intercepted EM radiation. When a dielectric
coefficient of a tissue and/or an organ changes, mainly the
amplitude but also the phase of the intercepted EM radiation may
respectively change. Multiple CW signals with spatial resolution
thereof are indicative to a localized movement and/or displacement
and/or dielectric related changes.
[0158] As described above, the CW radio signals may be transmitted
in one or more continuous or intermittent EM radiation sessions. In
such an embodiment, known changes in internal organs may be used
for performing differential measurements that may be indicative of
dielectric related properties of a monitored tissue and/or organ.
Examples for physiological processes during which the changes in
the internal organs are known may be heart beat cycle and/or a
breathing cycle.
[0159] For example, the breathing cycle changes the dielectric
coefficient of the pulmonary tissue. Such a change affects mainly
the amplitude but also the phase of a CW signal which is reflected
from the pulmonary tissue. A record that documents changes in the
dielectric coefficient of the pulmonary tissue during at least one
breathing cycle may be used as a reference for monitored tissues
and/or organs, for example monitoring the fluid content in a
monitored pulmonary tissue, for example as described in
International Patent Applications Numbers IL2008/001198 and
IL2008/001199, filed on Sep. 4, 2008, which are incorporated herein
by reference.
[0160] In another exemplary embodiment, the dielectric coefficient
of a pulmonary tissue may be monitored by tracking a differential
measurement calculated based on the intercepted EM radiation from
the interface between the lung and the heart during the systolic
and diastolic phases of the cardiac cycle. As the movements of the
heart are relatively rapid .about.1 hertz (Hz) with respect to
posture changes and movement, such a calculation reduce the effects
of posture change and movement.
[0161] Reflections from the heart through the lung are changed, in
phase and/or amplitude, during a systole diastole cardiac cycle. In
some embodiments of the present invention, these reflections are
used to evaluate a fluid content in a monitored pulmonary tissue.
Thus, in order to improve the accuracy of this evaluation, the
effect of the systole diastole cardiac cycle on the reflection has
to be taken into account.
[0162] Changes in the phase and amplitude of EM radiation
intercepted from the heart through the lung are indicative of
dielectric related properties changes where the measurement itself
is posture resilient. In particular, the phase of the
systole-diastole differential measurement is indicative of a
dielectric related change in the lung. Changes in the concentration
of fluids in the lung affect the phase velocity (EM radiation
propagation speed) and therefore may be used for evaluating the
fluid content in the lung. The amplitude of the differential signal
is also indicative to dielectric related change in the lung, as a
pulmonary tissue with a certain concentration of fluids absorbs
more of EM radiation that propagates therethrough than a pulmonary
tissue with a lower concentration. The higher is the absorptions of
reflections the lower are the reflections from the heart.
Optionally, the reduced effect of the posture on the reflections is
identified and further reduced using the posture detection methods
which are described below.
[0163] In some embodiments of the present invention, the one or
more EM transducers use a simplified narrow band and/or a
multiple-band antenna, with one continuous band or several bands,
which are matched to the monitored tissue and/or organ. Optionally,
a placement mechanism or unit, such as the placement unit which is
described below, is used for shifting the matching bands of the
antenna according to the positioning thereof. Optionally, the CW
signals are shifted each separately or jointly, so as to achieve
optimal sensitivity to one or more parameter, such as shifts in
respiration and heart rates.
[0164] Optionally, the CW signals referred to in this patent are
equivalent to narrow-band signals, and all descriptions referred to
such CW signals may be equivalently referred to the narrow-band
signals. As used herein a narrow-band signal means a signal
spreading over a small frequency band, for example up to 50 MHz,
optionally modulated and used to expand the band of the transmitted
energy. Such modulation may be frequency hopping, chirp,
frequency-shift keying (FSK), phase-shift keying (PSK), amplitude
Shift Keying (ASK) and the like. In such an embodiment, the EM
transducers may de-modulate the reflections to compress the band
back before further filtering and detection for improved
sensitivity and dynamic range.
[0165] Optionally, the frequencies of the narrow band signals are
900 Mega Hertz (MHz) and/or 2.4 gigahertz (GHz) industrial,
scientific, and medical (ISM) bands. Optionally, two frequencies,
such as the aforementioned two frequencies, may be combined to
improve time resolution and/or to separate reflections from
neighboring interfaces, or may be used for improved sensitivity. In
such an embodiment, the lower frequency penetrates deeper and less
sensitive to small displacements. In such an embodiment, radiation
in different frequency may be produced sequentially or
simultaneously.
[0166] Optionally, narrow-band signals may be used jointly with
pulsed wideband signals so as improve the overall sensitivity and
robustness of the transmission session. As commonly known, a narrow
band antenna is directive and allow more power to be used for the
narrow band signals. Optionally, the pulse wideband transmission
may achieve improved spatial resolution while the narrow band
signals may improve the penetration depth and extract information
from deeper layers.
[0167] Optionally, the one or more front-end sensors 204 includes
additional medical sensors, such as an electrocardiogram (ECG), an
electromyogram (EMG), ultrasound transducers, pulse oximeters,
blood pressure sensors, accelerometers, tilt-meters, coagulometers,
and optical blood saturation detectors.
[0168] In one example of the present invention, the wearable
monitoring device is attached to the skull of a user and used for
monitoring a build up of intra-cranial edema fluid which may be a
consequence of a head injury. The device may be focused on a
specific location according to inputs from an imaging modality such
as an MRI and/or a CT modality, either automatically and/or through
a manual user interface. Alternatively, a broad region should be
monitored either by a wide range of irradiated region from a single
device or by a multiple transducers in a configuration as described
below. The monitoring period is relatively short of few days, and
the measurements frequency is relatively high specifically right
after initial placement of every few minutes.
[0169] Optionally, the one or more front-end sensors 204 include
one or more EM transceivers which are designed for generating sharp
pulses. Optionally, the EM transceivers are connected to and/or
include one or more amplifiers, such as a low noise amplifier
(LNA). Optionally, the EM transceiver having a slim profile that
allows the manufacturing of a slim monitoring device 100, for
example as described in International Patent Applications Numbers
IL2008/001198 and IL2008/001199, filed on Sep. 4, 2008 which are
incorporated herein by reference.
[0170] Optionally, the EM transceiver is designed for sampling
pulse signals which are echoed from an internal area in the body of
the user, such as the pulmonary tissues, and indicative of the
dielectric related properties of fluids, such as water, blood,
and/or inflammation fluids therein.
[0171] Optionally, each EM transceiver utilizes one or more
antennas for transmitting and/or intercepting EM signals. Each
antenna may be configurable by setting antenna controls.
[0172] In some embodiments of the present invention, the antenna is
a low reverberation antenna, such as a planar wide band antenna
adapted for reducing the effect of reverberations upon the quality
of signal transmission. Such an antenna produces a short duration
fast-decaying pulses for improved time and range resolution.
Optionally, the antenna terminates the radiation using lumped
resistors to reduce reverberations, which may be referred to as
re-ringing of currents, from the far end of the antenna and emulate
an infinite antenna, without a need for printing tapered resistive
layers.
[0173] A Reference Intrabody Region
[0174] According to some embodiments of the present invention, the
monitoring device is designed to monitor a reference intrabody
region for allowing the detection of a reference dielectric related
change. The reference dielectric related change is used in
combination with the dielectric related change for detecting a
physiological pattern, for example as described above. For example,
the reference dielectric related change may be used for scaling,
calibrating, and/or adjusting the dielectric related change. The
detected dielectric related changes may be used for notifying the
patient and/or the caretaker about various physiological patterns
in the intrabody region, for example as described above.
Optionally, the reference intrabody region and the intrabody region
are selected from the same organ. In such a manner, a physiological
pattern may be identified when a difference between the dielectric
related change and reference dielectric related change is formed,
for example when blood is accumulated in the intrabody region and
not in the reference intrabody region. Optionally, the reference
intrabody region and the intrabody region are selected from similar
organs such as the left and the right lung. In such an embodiment,
a physiological pattern may be identified when a difference between
the dielectric related change and reference dielectric related
change is formed when fluid is accumulated in one of the lungs.
Optionally, the monitoring device comprises two or more probes for
separately monitoring the two regions. Optionally, the probes share
the processing units 201-203. Optionally, each probe is a separate
unit having separate processing units. Each probe monitors the
changes of dielectric related properties in one region for example
a lung, for example similarly to the described in International
Patent Applications Numbers IL2008/001198 and IL2008/001199, filed
on Sep. 4, 2008 which are incorporated herein by reference and to
the described above. In another embodiment, a single sensor
switches between a number of different reception states, such as
different reception angles, or depths, for intercepting reflections
from another region. The sensor may include two or more radiating
elements for allowing beam stearing as described in International
Patent Applications Numbers IL2008/001198 and IL2008/001199, filed
on Sep. 4, 2008 which are incorporated herein by reference. The
dual monitoring allows matching between two different readings
and/or the two different analysis outputs. Comparing readings may
allow a detection of physiological processes as the mismatch
between the measured dielectric related properties is associated
with an estimated change in the regional dielectric related
properties.
[0175] The measurement of the ventilation by multiple probes
positioned with respect to each lung or lobe, may indicate the
efficacy of the ventilation of a respective lung, and providing
sequential measurements may provide indication regarding
exacerbation or amelioration processes in any of the lungs.
Differences between the measurements of the two probes may indicate
a difference in the efficacy of the ventilation of the lungs. The
probes may be wearable and/or designed to be positioned in distance
from the patient in static position. The static positioning is
mostly suitable for neonates who are considerably static for long
periods.
[0176] For example, FIG. 9 depicts a method for detecting a
pathological pattern of a pulmonary tissue by combining dielectric
related changes in the reference intrabody region and the intrabody
region, for example in the left lung and in the right lung,
according to some embodiments of the present invention. Blocks 99
and 104 are as described in relation to FIG. 1. However FIG. 9
further describes the calculation of a reference dielectric related
change in a reference region, as shown 401 and the combination of
the reference dielectric related change with the dielectric related
change, as shown at 402, for evaluating a pathological pattern, as
shown at 404.
[0177] Optionally, reflections of EM radiations are intercepted
from the reference intrabody region and the intrabody region, for
example using the aforementioned probes, simultaneously,
alternately, and/or sequentially. The intercepted reflections allow
calculating the dielectric related changes, each for example as
described above. Then, as shown at 402, the dielectric related
changes are combined. The combination allows, as shown at 403,
identifying, for example by a match with a set of records, a
substation, and/or scaling, the identification of a pathological
pattern in the intrabody region and/or in the reference intrabody
region. Now, as shown at 104, a notification indicating the
pathological pattern is outputted, optionally in a similar manner
to the described above.
[0178] It is expected that during the life of a patent maturing
from this application many relevant systems and methods will be
developed and the scope of the term a radiation, a monitoring
device, and an EM radiation session is intended to include all such
new technologies a priori.
[0179] As used herein the term "about" refers to .+-.10.
[0180] The terms "comprises", "comprising", "includes",
"including", "having" and their conjugates mean "including but not
limited to". This term encompasses the terms "consisting of" and
"consisting essentially of".
[0181] The phrase "consisting essentially of" means that the
composition or method may include additional ingredients and/or
steps, but only if the additional ingredients and/or steps do not
materially alter the basic and novel characteristics of the claimed
composition or method.
[0182] As used herein, the singular form "a", "an" and "the"
include plural references unless the context clearly dictates
otherwise. For example, the term "a compound" or "at least one
compound" may include a plurality of compounds, including mixtures
thereof.
[0183] The word "exemplary" is used herein to mean "serving as an
example, instance or illustration". Any embodiment described as
"exemplary" is not necessarily to be construed as preferred or
advantageous over other embodiments and/or to exclude the
incorporation of features from other embodiments.
[0184] The word "optionally" is used herein to mean "is provided in
some embodiments and not provided in other embodiments". Any
particular embodiment of the invention may include a plurality of
"optional" features unless such features conflict.
[0185] Throughout this application, various embodiments of this
invention may be presented in a range format. It should be
understood that the description in range format is merely for
convenience and brevity and should not be construed as an
inflexible limitation on the scope of the invention. Accordingly,
the description of a range should be considered to have
specifically disclosed all the possible subranges as well as
individual numerical values within that range. For example,
description of a range such as from 1 to 6 should be considered to
have specifically disclosed subranges such as from 1 to 3, from 1
to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as
well as individual numbers within that range, for example, 1, 2, 3,
4, 5, and 6. This applies regardless of the breadth of the
range.
[0186] Whenever a numerical range is indicated herein, it is meant
to include any cited numeral (fractional or integral) within the
indicated range. The phrases "ranging/ranges between" a first
indicate number and a second indicate number and "ranging/ranges
from" a first indicate number "to" a second indicate number are
used herein interchangeably and are meant to include the first and
second indicated numbers and all the fractional and integral
numerals therebetween.
[0187] It is appreciated that certain features of the invention,
which are, for clarity, described in the context of separate
embodiments, may also be provided in combination in a single
embodiment. Conversely, various features of the invention, which
are, for brevity, described in the context of a single embodiment,
may also be provided separately or in any suitable subcombination
or as suitable in any other described embodiment of the invention.
Certain features described in the context of various embodiments
are not to be considered essential features of those embodiments,
unless the embodiment is inoperative without those elements.
* * * * *